Pharma powerhouse Merck has unveiled final results from its pivotal Phase 3 KEYNOTE-B96 trial, showing that KEYTRUDA (pembrolizumab) combined with chemotherapy significantly extends overall survival (OS) in patients with platinum-resistant recurrent ovarian cancer. 

 

At a median follow-up of 32.7 months, KEYTRUDA plus paclitaxel with or without bevacizumab reduced the risk of death by 18% compared to paclitaxel with or without bevacizumab alone. Median OS reached 17.7 months for the KEYTRUDA regimen versus 14.0 months for the control arm—among the longest survival times reported in any trial for platinum-resistant ovarian cancer.

 

“Patients with platinum-resistant ovarian cancer show reduced responses to traditional treatment regimens and may experience poor overall survival,” said Nicoletta Colombo, director of the Gynecologic Oncology Program at the European Institute of Oncology in Milan, Italy. “These results build on prior data from the KEYNOTE-B96 trial and further define the clinical impact of this pembrolizumab-based regimen in appropriate patients with platinum-resistant recurrent ovarian cancer.”

 

KEYTRUDA had previously met its primary endpoint of progression-free survival (PFS) in all patients, as well as in those with PD-L1-positive tumors, at the European Society for Medical Oncology (ESMO) Congress 2025.

 

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recently issued a positive opinion recommending approval of KEYTRUDA with paclitaxel—with or without bevacizumab—for adults with platinum-resistant ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 and who have received one or two prior systemic treatments. In February, the U.S. FDA granted approval for the same population.

 

“Results from the final analysis of KEYNOTE-B96, including overall survival data in the all comers population, demonstrate the continued clinical benefit of KEYTRUDA plus paclitaxel with or without bevacizumab for certain patients with platinum-resistant recurrent ovarian cancer,” said Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. 

 

“Taken together, the recent FDA approval and CHMP positive opinion underscore our commitment to the ovarian cancer community and our ongoing focus on delivering therapies that can help patients with unmet needs across women’s cancers.”